Sanofi’s new diabetes combo hits PhIII targets

A new diabetes combination therapy being developed by Sanofi has hit targets in two pivotal Phase III studies, showing a superior reduction in blood glucose compared to insulin glargine and versus lixisenatide.

The therapy is a fixed-ratio combination of the basal insulin glargine (marketed as Lantus) and GLP-1 receptor agonist lixisenatide, which has been approved in some countries as under the tradename Lyxumia.

LixiLan-O investigated the efficacy and safety of a once-daily single injection of Sanofi's combination versus treatment with either lixisenatide or insulin glargine alone over a 30 week period in 1,170 patients whose type II diabetes was not adequately controlled with metformin alone in combination with a second oral anti-diabetic agent.

Also of note, mean body weight increased with insulin glargine (+1.1kg), but decreased with the fixed-ratio combination (-0.3 kg) and lixisenatide (-2.3kg).

The LixiLan-L trial assessed the combination versus insulin glargine over a 30 week period in 736 patients whose type II diabetes was not adequately controlled at screening on basal insulin, alone or combined with one to two oral anti-diabetic agents.

On the safety side, the most frequent side effects reported in both studies were nausea, vomiting and diarrhoea, Sanofi noted.

The results of the LixiLan-O and LixiLan-L trials have been included in regulatory submissions in the US and Europe, with decisions expected in August (FDA) and early next year (EMA). A US decision on lixisenatide is expected in July.